Nab-Paclitaxel + Paclitaxel + Ramucirumab for Stomach Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: City of Hope Medical Center

Must not be taking: Antibiotics

Disqualifiers: Brain metastases, Intolerance to taxanes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 24 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for stomach cancer that has spread to the tissue lining the abdominal area. The study tests the safety and optimal dose of nab-paclitaxel, a chemotherapy drug delivered as a high-pressure mist directly into the abdomen, combined with paclitaxel and ramucirumab, a targeted therapy that may inhibit tumor growth and blood vessel formation. It suits individuals with spreading stomach cancer who did not respond to their first round of systemic therapy. Participants should show visible signs of cancer spread in the abdomen and must have tried specific chemotherapy regimens. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it does mention that treatment with therapeutic oral or IV antibiotics within 14 days prior to the start of the trial is not allowed, unless they are prophylactic (preventive) antibiotics and signs of active infection have resolved.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies found nab-paclitaxel to be a safe option for patients with advanced stomach cancer. Patients tolerated it well as a second treatment option and did not report major side effects, making it promising.

Research on paclitaxel, another chemotherapy drug, shows it is generally safe for patients with advanced stomach cancer. It remains safe and manageable when combined with other treatments.

Ramucirumab, already approved by the FDA for other types of stomach cancer, also appears safe. Studies have shown that it helps when used with paclitaxel, and patients handle it well.

These findings suggest that the combination of nab-paclitaxel, paclitaxel, and ramucirumab has a good safety record, indicating that the treatment may be safe for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of nab-paclitaxel, paclitaxel, and ramucirumab for stomach cancer because it brings together powerful therapies in a novel way. Unlike most treatments that rely solely on intravenous delivery, this approach includes nab-paclitaxel PIPAC, which administers the drug directly into the abdominal cavity, potentially enhancing its effectiveness against tumors. Additionally, ramucirumab works by blocking blood vessel growth that tumors need, offering a targeted mechanism that complements the chemotherapy agents. This combination aims to improve outcomes by attacking the cancer from multiple angles, thereby offering hope for better control of the disease.

What evidence suggests that this trial's treatments could be effective for stomach cancer with peritoneal metastases?

In this trial, participants will receive a combination of nab-paclitaxel, paclitaxel, and ramucirumab. Studies have shown that nab-paclitaxel can help treat advanced stomach cancer by increasing the likelihood of the cancer shrinking and slowing its growth. Research indicates that paclitaxel, especially when combined with ramucirumab, serves as an effective second option for treating advanced stomach cancer, showing better results than other treatments. The FDA has approved ramucirumab for advanced stomach cancer; it works by blocking the growth of blood vessels that tumors need to grow. This trial aims to use these treatments together to be more effective against stomach cancer that has spread to the lining of the abdomen. Early findings suggest that delivering nab-paclitaxel directly into the abdomen may increase its concentration at the tumor site, potentially enhancing its effectiveness. ^{1 2 4 5 6}

Who Is on the Research Team?

Yanghee Woo

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for stomach cancer patients with peritoneal metastases, who are ready to try a combination of treatments. Participants should be suitable for second-line chemotherapy and have not had prior PIPAC or allergic reactions to the drugs used in this study.

Inclusion Criteria

My urine protein levels are low or normal.

I've had a full medical check-up in the last 28 days.

Platelets ≥ 100,000/mcL (within 28 days prior to day 1 of protocol therapy)

Exclusion Criteria

I cannot tolerate taxane medications.

I am not pregnant or breastfeeding.

Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive nab-paclitaxel PIPAC intraperitoneally and standard of care paclitaxel and ramucirumab intravenously. Cycles repeat every 8 weeks for up to 3 cycles.

24 weeks

Multiple visits for each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment completion. Follow-up includes regular assessments every 3 months for the first year, then every 6 months.

Up to 2 years

Regular visits every 3 to 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Nab-paclitaxel
• Paclitaxel
• Ramucirumab

Trial Overview

The trial tests nab-paclitaxel PIPAC's safety and optimal dose when combined with paclitaxel and ramucirumab. It evaluates how well these treatments work against stomach cancer that has spread to the abdominal lining.

How Is the Trial Designed?

Group I: Treatment (nab-paclitaxel PIPAC, paclitaxel, ramucirumab) Experimental Treatment 9 Interventions

Patients receive nab-paclitaxel PIPAC IP over 40 minutes on day 1 and SOC paclitaxel IV over 60 minutes on days 15, 22, 29, 43, and 50 and ramucirumab IV over 30-60 minutes on days 15, 29 and 43 of each cycle. Cycles repeat every 8 weeks (56 days) for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients may then continue SOC paclitaxel IV on days 1, 8, and 15 and ramucirumab IV on days 1 and 15 of each cycle per physician as deemed appropriate. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, tumor biopsy, and CT or MRI throughout the study.

Nab-paclitaxel is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Abraxane for:

• Metastatic breast cancer
• Non-small cell lung cancer
• Adenocarcinoma of the pancreas

Approved in European Union as Abraxane for:

• Metastatic breast cancer
• Non-small cell lung cancer
• Adenocarcinoma of the pancreas

Approved in Canada as Abraxane for:

• Metastatic breast cancer
• Non-small cell lung cancer
• Adenocarcinoma of the pancreas

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study involving 17 patients with malignant solid tumors, nab-paclitaxel (Abraxane) showed a significantly higher exposure to unbound paclitaxel compared to solvent-based paclitaxel, which may enhance its effectiveness against tumors.

The pharmacokinetics of nab-paclitaxel remained consistent across treatment cycles, indicating stable drug behavior and suggesting improved tolerability and efficacy due to its unique formulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized crossover pharmacokinetic study of solvent-based paclitaxel and nab-paclitaxel. Gardner, ER., Dahut, WL., Scripture, CD., et al.[2022]

Nab-paclitaxel, a new formulation of paclitaxel, has shown a good safety and efficacy profile for treating metastatic breast cancer (MBC), although there is limited data on its impact on overall survival.

In combination with gemcitabine, nab-paclitaxel significantly improves survival in advanced pancreatic cancer (PC) and demonstrates better results in non-small-cell lung cancer (NSCLC) patients with squamous histology, highlighting its potential as a valuable treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy evaluation of albumin-bound paclitaxel. Cecco, S., Aliberti, M., Baldo, P., et al.[2015]

Nab-paclitaxel, a nanoparticle albumin-bound form of paclitaxel, is the first nanotechnology-based drug approved for cancer treatment, showing significant promise in breast and pancreatic cancers.

This innovative drug not only enhances the effectiveness and reduces the toxicity of traditional treatments but also demonstrates activity in cancers that typically do not respond to standard taxane therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nanoparticle albumin bound Paclitaxel in the treatment of human cancer: nanodelivery reaches prime-time? Cucinotto, I., Fiorillo, L., Gualtieri, S., et al.[2022]

In a study involving 74 patients with metastatic melanoma, nab-Paclitaxel showed a response rate of 21.6% in chemotherapy-naive patients and 2.7% in previously treated patients, indicating better efficacy in those who had not undergone prior treatment.

The treatment was well tolerated, with 78% of previously treated patients and 49% of chemotherapy-naive patients able to complete therapy without dose reductions, suggesting a favorable safety profile compared to standard therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 2 clinical trial of nab-paclitaxel in previously treated and chemotherapy-naive patients with metastatic melanoma. Hersh, EM., O'Day, SJ., Ribas, A., et al.[2020]

Nab-paclitaxel was well tolerated in pediatric solid tumor models, with a maximum weight loss of about 10% that returned to baseline after treatment, indicating a favorable safety profile.

The treatment showed significant efficacy, improving event-free survival in 19 out of 20 solid tumor xenograft models, particularly demonstrating high activity against Ewing sarcoma and rhabdomyosarcoma, making it a promising candidate for further pediatric evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial testing (stage 1) of the tubulin binding agent nanoparticle albumin-bound (nab) paclitaxel (Abraxane(®)) by the Pediatric Preclinical Testing Program (PPTP). Houghton, PJ., Kurmasheva, RT., Kolb, EA., et al.[2022]

In a phase II trial involving 45 patients with advanced gastric cancer, the combination of nab-paclitaxel and ramucirumab achieved an overall response rate of 54.8%, indicating significant efficacy as a second-line treatment.

The treatment was associated with manageable side effects, primarily decreased neutrophil and white blood cell counts, but no treatment-related deaths occurred, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase II study of nab-paclitaxel in combination with ramucirumab in patients with previously treated advanced gastric cancer. Bando, H., Shimodaira, H., Fujitani, K., et al.[2023]

In a phase II study involving 43 patients with non-small-cell lung cancer, Abraxane (260 mg/m2) demonstrated a 16% overall response rate and a 49% disease control rate, indicating its efficacy as a first-line therapy.

Abraxane was well tolerated, with no severe hypersensitivity reactions reported and only 5% of patients discontinuing treatment due to mild toxicities, suggesting a favorable safety profile for this novel formulation of paclitaxel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abraxane, a novel Cremophor-free, albumin-bound particle form of paclitaxel for the treatment of advanced non-small-cell lung cancer. Green, MR., Manikhas, GM., Orlov, S., et al.[2022]

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This study has demonstrated three important findings. First, nab-paclitaxel is safe for second- or later-line chemotherapy for advanced/recurrent gastric cancer ...

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